Its goal is to demonstrate the clinical utility of minimal invasive diagnostic HER2DX® by improving quality of life and reducing toxicities and direct and indirect costs, as well as maintaining the efficacy endpoints and survival outcomes compared to patients treated without the test.
The DEFINITIVE project will receive 8 million euros from Horizon Europe under the HORIZON-MISS-2023-CANCER round of funding, as part of the European Commission’s key funding program for research and innovation. By bringing “specific solutions to some of our greatest challenges”, EU Mission Cancer aims to improve, by 2030, the lives of over 3 million individuals affected by cancer, along with their families, through prevention and cure, enabling them to live longer and better.
This landmark study will be pivotal in bolstering the clinical validations already acquired for HER2DX®. The study seeks to secure the prospective validation for endorsement by clinical guidelines and ensure recognition and reimbursement across Europe. As a collaborating partner in this study, REVEAL GENOMICS® is committed to generating robust evidence designed to influence and evolve standard clinical practices.
Dr. Tomás Pascual, medical oncologist, researcher at Hospital Clínic/IDIBAPS, SOLTI executive board member, and Principal Investigator in the DEFINITIVE clinical trial, expressed his optimism about the trial’s potential impact, “This trial represents a significant opportunity to enhance patients’ quality of life without compromising the efficacy of the treatment. It employs a non-invasive diagnostic tool, HER2DX®, to achieve this goal. We are immensely grateful to all our partners and the multidisciplinary team participating in this trial. Their collaboration has been instrumental in developing this project and will be crucial to its successful delivery.”
Dr. Patricia Villagrasa, CEO and co-founder of REVEAL GENOMICS®, stresses that “at REVEAL GENOMICS, we believe in pushing the boundaries of precision medicine. The start of the DEFINITIVE study for HER2DX® is a crucial step in our journey to reshape how oncology treatments are approached and administered globally.”
HER2DX®: seeking to change the paradigm in HER2+ breast cancer
Recent progress in treating HER2-positive breast cancer has significantly shifted the emphasis from post-surgery therapies to treatments administered prior to surgery. This shift offers multiple benefits, which include reducing tumor stages for less invasive surgeries, evaluating tumor response to systemic treatments, and tailoring adjuvant treatments based on the pathological responses observed during surgery.
Moreover, coupled with significant progress in early-stage HER2+ breast cancer treatment through chemotherapy with multiple drugs and targeted therapies, it also means a more optimistic outlook for patients. However, unmet needs and unanswered questions persist.
Firstly, some patients still face recurrence, despite current treatments. Secondly, most patients could be cured using less aggressive treatments. Moreover, the acute and long-term side effects from anti-HER2 agents and chemotherapy underscore the need for tools that offer deeper insights into tumor behavior, treatment responses, and risk of recurrence.
The DEFINITIVE trial seeks to assess the clinical efficacy of genomic test HER2DX® by comparing the outcomes of patients who undergo the genomic test with those who do not. This study will crucially ascertain the real-world applicability of HER2DX® in clinical settings.
HER2DX® is a genomic test for personalized HER2+ breast cancer treatments, able to predict survival outcomes and the likelihood that patients will respond to treatment.
A thorough evaluation of the test’s implementation strategies, its cost-saving benefits, and its introduction in various European contexts is integral to the DEFINITIVE study’s role in broadening access to HER2DX® by all patients.
The DEFINITIVE study: making results accessible
The kickoff meeting for the DEFINITIVE project was held at IDIBAPS headquarters on January 11 and 12. More than 30 people from all participating entities from 9 different countries met to lay the foundations of the project and initiate each of the actions proposed in a coordinated manner.
“The start of the DEFINITIVE trial is fundamental for the prospective validation of HER2DX® clinical utility. Moreover, it addresses crucial areas, including an extensive health technological assessment and patients’ perspectives, incorporating their views during all the phases of the project”, says Dr. Olga Martínez Sáez, medical oncologist and researcher at Hospital Clínic/IDIBAPS, and Co-Principal Investigator in the DEFINITIVE clinical trial.
The study brings together a group of international experts in breast cancer from leading hospitals, as well as experts in medical statistics, comprehensive cancer networks, and clinical trials; regulatory experts; Health Technology Assessment (HTA) experts; innovative Small and Medium Enterprises (SMEs) related to technology; policymakers; patient associations; living labs; and medical societies.
The DEFINITIVE study will be a collaborative effort involving 18 esteemed entities from across the healthcare and research spectrum. This includes leading hospitals, research groups, universities, and cancer care organizations. Participants include the following:
- Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (SPAIN)
- Hospital Clínic de Barcelona (SPAIN)
- SOLTI Breast Cancer Research Group (SPAIN)
- UNICANCER (FRANCE)
- Westdeutsche Studiengruppe GmbH (GERMANY)
- Austrian Breast & Colorectal Cancer Study Group (AUSTRIA)
- Università degli Studi di Padova (ITALY)
- Istituto Oncologico Veneto IRCCS (ITALY)
- Istituto Europeo di Oncologia (ITALY)
- University College Cork - National University of Ireland (IRELAND)
- The Sheba Fund for Health Services and Research (ISRAEL)
- ERASMUS University Rotterdam (NETHERLANDS)
- Center for Medical Data Science, Medical University of Vienna (AUSTRIA)
- Institut Català d’Oncologia (SPAIN)
- Europa Donna - European Breast Cancer Coalition (ITALY)
- Société Internationale d’Oncologie Gériatrique (SWITZERLAND)
- Sharing Progress in Cancer Care (SPCC) (SWITZERLAND)
- Reveal Genomics S.L. (SPAIN)
In addition to the clinical and logistical aspects of the study, we will take a comprehensive approach in order to ensure broad access to the test within society. This approach encompasses various initiatives:
- Health Technology Assessment (HTA) Strategies: to evaluate the test’s effectiveness and value in a healthcare setting.
- Patient-Oriented Events: to inform and engage patients directly, thereby enhancing their understanding and acceptance of the test.
- Continuing Education for Healthcare Professionals: to keep medical practitioners abreast of the latest developments and applications of the test.
- Communication and Dissemination Efforts: targeting the general public, these actions are designed to raise awareness and knowledge about the test and its potential benefits.
